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Sincerely Yours,
Editor-in-Chief:
Chime Y. Mishra (MBA Biotechnology - SEM IV)
The PUMBA Gazette Team
(The detailed project report shall be provided on enquiry.
Kindly send in your enquiries at
thepumbagazette@gmail.com)
1
Cover Story
CANCER DRUGS AVAILABLE… kinds of drugs yet or if they are being developed the long
duration between the approvals and the commercial
BUT UNAVAILABLE… availability is the negating factor as many lives are lost
The Oncology market has grown at more than double due to lack of treatment in this duration. Some also find
the rate of global pharmaceuticals, with a CAGR of 8.39% one of the reasons to be the withdrawal of the drugs
during 2004–’08. But does the ultimate cause of any drug
development actually being achieved? Even with this
increase in the available drugs as well as reported cases,
are these drugs reaching the final consumer i.e., the
Patient? It is a rarely asked question but an important
one in analyzing the role of pharma companies in
contributing to the oncology treatments. It was the main
objective of this month’s survey by the PUMBA Gazette
team i.e., to assess the availability of cancer drugs to
patients in all terms: drug development, market capture,
cost factor, lack of quick approvals and withdrawals.
The oncologists in the Pune region were interviewed to
gather the information on the availability of drugs, the
reason for this non availability and chiefly the role
pharma companies are playing in making these drugs which were found effective for disease curing owing to
available to patients. the potential side-effects. E.g. Mylotarg of Wyeth which
was approved under the accelerated approval program of
AVAILABILITY OF DRUGS FDA used for the treatment of relapsed acute myeloid
The most incident cancers in Pune were found to be leukaemia (AML). It has been withdrawn owing to lack of
breast, cervical, oral and lung cancers with the most any additional clinical benefit and increased toxicity when
recovered one to be breast cancer due to ample drugs administered with chemotherapy. Another of the main
reasons was also found to be that a few drugs have not
yet been approved in India depriving Indian patients of
the benefits.
COST FACTOR
According to the survey of the PUMBA Gazette team, in
Pune region, almost 70% of the oncologists think that the
drug price being high affects the percentage of patients
recovering from cancer (recovery percentage). The
oncologists have almost 80 % of the patients visiting
them for treatment from lower and middle economic
strata (35% Low, 45% Middle). With this high share of
economically not well-to-do patients with not much of
income to spend in the costly cancer treatment, many
patients die untreated or have to withdraw in the middle,
i.e., less recovery percentage.
A study proves that the newly developed drugs are
available on the basis of an analysis on the availability of costing even higher than the already available drugs.
drugs for certain types of cancer. Drugs are ample for Some of the newly-approved brands cost USD 150-500K
Lymphoma too. However, the drugs are found to be just per life year gained.
enough for the treatment of lung cancer, prostate cancer, “...the addition of ixabepilone to capecitabine
ovarian cancer, colorectal cancer and leukaemia. (Xeloda) adds about $31,000 to the overall medical
According to oncologists the drugs are scarcely available costs of metastatic breast cancer while providing
for treatment of pancreatic cancer. about 1 more month of ‘quality-adjusted’ survival”.
Journal of Clinical Oncology, May 1, 2009.
REASONS FOR NONAVAILABILITY
Most of the doctors think high drug costs to be the chief This and many more studies suggest that the drugs’ reach
reason for unavailability of the drugs followed by non to the economically backwards is reducing. Ironically,
development and lack of approvals and trials duration. with the development of newer drugs this class of society
There are many indications for which we don’t have any
2
is getting even more deprived of treatment due to high less than $75000/year before its withdrawal. Amgen has
costs. a price cap on Vectibix™ in USA since 2006 at $4000/
dose, approximately 20% less than the other antibody on
WHY THE COSTS ARE HIGH? the market (BMS’s Erbitux®) for metastatic colorectal
Almost 50% of doctors directly blame the high costs of cancer. Another of these initiatives are the Pay-for-
drugs on the pharma companies saying that the motive Performance programs, e.g., in Britain, Johnson &
behind such high prices is just high profit as they are Johnson offered a money-back guarantee if Velcade
ultimately doing a business and they are in business to failed to reduce tumours by at least 25%. However,
add to their bottom line inconsiderate to the fact that Indians are still waiting for any such price cap initiatives.
these drugs are necessities which need to reach more . The accelerated drugs approvals have been beneficial
and more people. They also think that the unavailability but a few people debate that whether accelerated
of any alternative also adds as an advantage to the approvals are improved access to therapeutic
companies’ high profit motive until any competition breakthroughs or early release of unsafe and ineffective
comes up. An equal number of respondents do not blame drugs? This question is going to remain as we have
it on the companies directly but the need to recover the examples on both the facets. Mylotarg was approved in
huge costs companies have put into the research and 2000 came out to be ineffective and withdrawn in June
development of these drugs as a reason behind the high 2010 and Cetuximab was approved under accelerated
prices. approval program in March 2004 for the treatment of
patients with metastatic colorectal cancer had till yet
ARE COMPANIES DOING ANYTHING? been proved good with a few non fatal side effects only.
A 29% of the oncologists’ perception is that the pharma There are several Patient advocacy groups also who assist
companies are just profit oriented and are not playing people in accessing the drugs through expanded access
any role in the drug reach increase. But a good 71% think programs and compassionate use programs which allow
that even being profit oriented some initiatives are being patients to receive investigational drugs earlier than
taken by the companies so as to make the drugs reach phase III of the clinical trial process i.e., earlier than the
more and more patients. They have rated Pfizer, BMS, FDA approval. When patient advocacy groups learned
Roche, Cipla and Novartis to be a few companies active in that Herceptin was showing promise in clinical trials, they
doing so along with Intas Pharmaceuticals, EliLilly, Dr. pressured the manufacturer, Genentech, to provide the
Reddy’s Laboratories and Innova Healthcare. Thirty drug early to certain patients.
percent of oncologists say that the companies are giving
free samples to the patients so as to make it reach the WHAT SHOULD COMPANIES DO?
poor. E.g., Novartis’ Gleevec®/Glivec® have been Many doctors suggest that the companies should focus
provided free to the needy patients in India through the more on research and development and the
multinationals should have their research centres in India
as the cost of drug development is found to be lesser in
India. The trials should be on larger scale involving more
and more people. The costing should be caps based done
on the basis of class and economic conditions of patients
being served. The rural market should be targeted as a
majority of population stays there and the facilities
should be provided to them not only getting the
companies reach more and more patients but also a
good-will creation in a larger mass. Many people lack
awareness so awareness programs could be a major
benefit to both the sides. Another way to reduce costs is
through licensing and supply deals across countries and
such collaborations which will finally reduce the costs
pressure on the patients. The parallel drug applications
i.e., a single drug to be applicable to other indications
Glivec International Patient Assistance Program (GIPAP). could also be a good way to increase availability, so
Patient friendly company policies, reduced costs and research should be directed in these directions as well.
accelerated approvals are few other initiatives by the
companies. Generics are a very good advantage for the Compiled By:
patients as they are the cheaper substitutes to their Richa Vijayvargiya, Shomali Naranje (MBA-BT SEM IV)
branded counterparts with the similar affectivity. A few Apoorva Joshi, Ektaa Sharma, Neha Shedge, Gurudeep S.
Dodmani, Vinay Pantulwar (MBA-BT SEM II)
companies are also involved in inducing voluntary price
caps on their drugs like Genentech had a price cap on
Avastin at $55000/ year for households having income
3
Article
“ONCO”NTROL Cancer vaccines represent an emerging type of biological
Cancer vaccines are medicines that belong to a class of therapy that is still mostly experimental. Many clinical
substances known as biological response modifiers. trials are underway to test vaccines as potential
Biological response modifiers work by stimulating or treatments for a wide variety of cancer types.
restoring the immune system’s ability to fight infections
and diseases. There are two broad types of cancer
vaccines:
* Preventive (or prophylactic) vaccines, which are
intended to prevent cancer from developing in healthy
people.
* Treatment (or therapeutic) vaccines, which are
intended to treat an existing cancer by strengthening the
body’s natural defenses against the cancer.
4
‘Innov’Era
‘CAN’CER TREATMENT: A REALITY!!! and the general population. This presents a sizeable
market opportunity. Research is being conducted in both
In India, cancer is a silent crisis. It goes largely
ovarian cancer and prostate cancer, which could have
unreported, and elicits little of the attention it deserves
wide-market implications. Specifically, companies are
from health authorities preoccupied with other pressing
looking to validate new biomarkers in order to create
health problems. Efforts at prevention and early
more accurate tests.
detection are extremely limited, as are diagnostic and
treatment services. Cancer survival rates in India are
Apart from commonly used chemotherapy, hormonal
exceptionally poor. Lack of awareness, stigma, and
therapy and radiotherapy, few therapies like stem cell
reliance on traditional healers mean most people do not
transplantation, electromagnetic radiation therapy,
seek medical help in time. Also, there is a common
dendritic cell (antigen presenting cells) based vaccines,
perception that cancer is transmissible, which leads to
antisense therapy etc. have emerged as novel ways to
patients being shunned by family and friends and inhibits
treat cancer. As the name suggests, stem cell
people from accessing screening or acknowledging early
transplantation is transplantation of multipotent
symptoms. More than two third of cancer patients are
hematopoietic stem cells or blood, often derived from
first seen with late stage disease, which has a poor
bone marrow, umbilical cord blood or hemopoietic stem
prognosis and is long, difficult and costly to treat.
cells derived from a placenta into the patient as part of
the therapy.
Despite public policy measures to prevent cancer, such as
tobacco control and vaccination against HPV (Human
In electromagnetic radiotherapy, low power, non-
Papilloma Virus), cancer is sure to remain a significant
ionizing, non thermal, radio or sub-radio frequency
public health problem throughout the 21st century. The
electromagnetic waves are produced which are helpful in
demographic shift towards an ageing population and the
treating the cancer.
usage of high–tech modern medicine throughout the
emerging economies of Asia and Africa will lead to the
A dendritic cell based cancer vaccine induces strong
expansion of the market for cancer diagnostics globally.
anticancer immunity by its potent immune-inducing
abilities. It is a new paradigm in cancer treatment which
Early diagnosis of cancer is essential to determine the
induces not only strong anti-tumour immunity but also
treatment regime. Computerized tomography, positron
immune memory to prevent tumour recurrence or
emission tomography, magnetic resonance imaging and
metastasis. In this vaccine a live attenuated virus is used
ultrasound imaging are some of the techniques used for
which infects both healthy cells and tumour cells but it
cancer detection. However these techniques are
selectively replicates in tumour cells resulting in killing
expensive, require lab facilities and highly trained
tumour cells and leaving healthy cells unaffected. It also
technicians, they are time consuming and cannot be
results in production of antigens which induces tumour
taken into the field. Nanotechnology is one of the recent
specific immune response, resulting in identifying and
technologies used for cancer diagnosis. Nanotechnology
destroying tumour cells systematically.
is in a unique position to produce a new generation of
early cancer detection techniques with higher sensitivity
Antisense therapy has emerged as an exciting and
and delivery of the drug to the target site.
promising strategy for cancer therapy which works at the
genetic level to prevent mutated or overactive genes by
The latest Technologies in Oncology Diagnostics range
directing the synthesis of proteins that are causing
from body imaging and cytology to molecular diagnostics
cancer. They are different
and pharmacogenomics. The imaging techniques involve
from conventional drugs
Magnetic Resonance Imaging (MRI), X-ray, Computed
as these are designed to
Tomography (CT), Ultrasound, Positron Emission
interact with protein
Tomography (PET), Single Photon Emission Computed
molecules after they are
Tomography (SPECT) and Flow Cytometry. Similarly, the
produced. Antisense
molecular diagnostics include Fluorescence In-Situ
drugs have a more
Hybridization (FISH), Polymerase Chain Reaction (PCR),
selective action, and they have the potential to be more
HPV testing, Immunoassays & Biomarkers, Microarrays
effective and less toxic than conventional drugs.
and Comparative Genomic Hybridization (CGH).
Molecular diagnostics and biomarkers are the key drivers
Compiled by:
of the oncology diagnostics market. Virtual colonoscopy,
Hitesh Patil (MBA-BT SEM IV)
using CT scans to build a picture of the colon, is becoming
Neha Shedge & Seema Pawar (MBA-BT SEM II)
an increasingly accepted alternative to invasive
colonoscopy for colorectal screening in high risk groups
5
The Industry Buzz
NOMORESULIDE… Paracetamol and Ibuprofen were trying to get the drug
banned because of the higher revenues it generated and
It seems that the Drug Technical Advisory Board of India it had nothing to do with the adverse effects it caused.
has pulled its socks and rolled its sleeves once again. It However the test results as well as the reports from the
has finally decided to impose ban on the market always pointed that the problems posed are
commercialization two very controversial drugs being serious and need attention.
sold in Indian market namely NIMESULIDE and PHENYL
PROPYLAMINE (widely known as PPA). The move comes BIOCON SUFFERS A SETBACK AS ORAL
after the debate that has lasted for a decade. The debate
was whether to ban Nimesulide in India or not. INSULIN TRIALS FAIL...
The Nimesulide drug has already been banned in the Biocon suffered a serious setback this month when the
developed countries like Britain, Canada, Sweden, results of the clinical trials on the much awaited oral
Denmark, New Zealand, Japan and many more. In USA insulin drug failed. The clinical trials on the drug failed to
the drug was not even filed for marketing. The main meet the primary goals.
reason behind the ban imposed on the drug is the severe
liver damage it causes. It was marketed in India despite of The drug is named as IN-105 by the company and had
being banned in the developed countries. cleared the Phase II of the clinical trials. The drug in
clinical trials has to prove the efficacy test to reach the
very important phase III. In the human clinical trials of IN-
105, it was supposed to lower the level of glycated
haemoglobin by 0.7% however it failed to lower the
levels as compared to placebo.
6
Candid Talk
AN INTERVIEW WITH MR. MANISH up with government organizations that can help bring
these tests to the common man at subsidized rates.
PUNGALIYA
Q.4. What is the current share of pharmacogenomics in
Pharmacogenomics can the Indian diagnostic industry? And what is your
be described as the study forecast for the next 5 years for this industry?
of the effects of genetic The current share of pharmacogenomics in the
variation on the efficacy diagnostics industry is somewhere around 5-6 %.
and toxicity of a particular However, this scenario will definitely change in the future
drug. Today oncology and pharmacogenomics is a hot as the growth potential is tremendous and the Indian
topic in the current diagnostics market. In order to molecular diagnostics market is expected to cross US$ 3
understand this association, the interview team spoke billion by 2015. In keeping with the proportion of the
with Mr. Manish Pungaliya, Director, Ayugen pharmacagenomics market share, there will be an
Biosciences. Ayugen is one of the few companies exceptional growth in this sector too.
currently working in the field of pharmacogenomics
testing. Q.5. What are the current as well as the untapped
opportunities in cancer pharmacogenomics?
Q.1. “Pharmacogenomics, a powerful tool to enhance There is a host of other tests that are available that can
cancer treatment”. What are your views on this be developed to check the side effects and efficacy of a
statement? drug in a patient’s body based on drug metabolism and
Pharmcogenomics is drawing attention towards itself in site of action. Also there are other genomics tests which
oncology because most of the new drugs to treat it are try and understand the gene and protein expression in
based on targeted therapies i.e. they target a particular the patient’s body once the drug has been administered.
pathway or a gene in a pathway or a protein. Therefore,
most of these drugs will only work based on a particular Q.6. What factors should a new entrant take into
genetic profile of the tumour. Pharmacogenomics can account before stepping into this field?
guide practitioners through its genetic profiling tests as A new entrant must keep in mind that they should be
well as about which medication will work in a patient and ready with a full fledged marketing plan and a proper
which won’t work. implementation plan to create awareness among the
practitioners. Another factor for consideration is to try
Q.2. Even though pharmacogenomics plays a vital role in and bring the cost down from the current levels. The
cancer treatment, do you think it is being utilised major aspect to be worked upon is the awareness levels
efficiently in India as compared to western countries? If in the market since it’s a new field in India. Initially the
not so, what do you think are the probable reasons for investment would be high but the returns on investment
its underutilisation? will certainly follow. Therefore any new entrant must
Pharmacogenomics is not being utilized to its full have enough patience to fuel this industry.
potential in our country because most of the doctors
don’t know about the tests and their usage. They are not Compiled by: The PUMBA Gazette Interview Team
aware about the benefits and the power of these tests
and even if the doctors are aware of the test they don’t
know how to apply them. But the bright side is that more
and more pharmaceutical companies are pushing the use
of these tests with their drugs, thus the awareness and
usage will increase rapidly in the future. There is also a
cost factor involved in the successful application of this
technique and currently it’s a barrier to the acceptance of
this form of therapy.
7
The PUMBA News
DHRUV ‘11 were adjudged as the best artists through a poll
conducted during the event. Thus, another event was
DHRUV ’11, one of the most awaited cultural events was
successfully organized by Alumni cell, the heart of
held from 17th -19thJan 2011. This year the theme for
PUMBA.
DHRUV was “AQUATICA.” This event gives the students,
from leading B-Schools, an opportunity to present their
managerial, cultural & sports skills to come out and NATIONAL SEMINAR 2011
perform in front of all & compete with others. More than National seminar 2011, a National level seminar, was
5000 participants registered their names for various held on 29th January, 2011 at Le Meridian, Pune. This
events. The Grand Finale was held on 19th Jan 2011 at year, the topic of discussion was ‘India on the horizon –
‘Alpabachat Bhavan’ which comprised of the finals for The dawn of a global era’. Dr. Santosh Bhave, Vice
‘dance competition’ and ‘fashion show’. The chief guest President - HR, Bharat Forge Ltd. graced the event as the
for the Grand Finale was Mr. Nandkishor Kapote, the Chief guest and Dr. R.K. Shevgaonkar, Hon. Vice
renowed Kathak dancer and disciple of Pandit Birju Chancellor, UoP, as the Guest of Honour along with Dr.
Maharaj. The judges for the evening were Abhilasha (Capt.) C.M. Chitale, the Head of Department of
Mahant Choudhary, Director ‘Nach India’ and Vikram , Management Sciences (PUMBA). The curtain raiser
Choreographer from Jhalak Dikhla Ja.’ The event movie, based on the theme, was an apt introduction of
concluded with overall prize distribution and tallying of the current Indian scenario. There were three panel
points won in various competitions. The General discussions in the seminar with the topics being India’s
Championship rolling Trophy is given on the basis of Global Footprint - How far have we reached?,
collective ranking in each individual event of DHRUV. For Infrastructure Jeopardized- Why can’t we walk the talk?
the third consecutive year the trophy for DHRUV’11 was and Globalization and National Commitment-Can they
won by Indira Institute Of Management, Pune. go hand in hand?. The panelists included Mr. Rajesh
Ghonasgi, CFO, Persistent Systems Ltd., Mr. Diniar
NOSTALGIA 2011 Patel, Editor-Supplement, Times Of India, Mr.
Unnikrishnan Menon, AGM - Exports, IPCA Labs, Dr. P C
Nostalgia`11, An Odyssey to Remember is an annual
Nambiar, Director - EXIM, Serum Institute of India, Mr. P
Alumni meet & was held on 22nd January, 2011 at the
Srinivasan, Global Business Head, Chemical Division,
PUMBA campus. This event is a casual gathering of
Thermax Ltd., and members of Faculty of PUMBA. The
alumni & is meant for recapturing the past memories of
seminar was concluded with a valedictory speech by Dr.
PUMBA. It’s an attempt to strengthen the relation
Ashok Joshi, Dean, Faculty of Management, University of
between PUMBA and its alumni. This year the event
Pune. With this seminar, the Seminar cell has indeed
revolved around the theme of ‘Journey’. Deviating from
added another feather in its cap!
the usual on-stage program, the PUMBA campus was
converted into a fete with various games organized by
the students. These were enjoyed by the alumni and the YUKTI
fun atmosphere pepped up the interactions. “Yukti” a business plan competition was organized by the
ED Cell at PUMBA campus on 25th January, 2011. The
event consisted of two segments. In the first segment,
“BIZZolution”, candidates were given 100 seconds to
present their business ideas. The second segment,
“BIZZplanmania”, only shortlisted candidates presented
their complete business plan. Students from leading B –
Schools like JBIMS, N.L. Dalmia, K.J. Somaiya, MIT,
Sinhgad Institute participated in these events. Reputed
Industrial personalities were invited to judge the business
plan competition. Vishwas Kale (Vijayesh Industries) and
K.J. Bhumkar (Ex-CMD, Bank of Maharashtra) were the
esteemed judges.
The Event was inaugurated by Dr. Capt. C.M. Chitale,
Professor and Head of Department, PUMBA. The alumni, Compiled by: Nazaneen Saify (MBA BT Sem IV)
who have helped PUMBA in the past year, were Mehraj Deshmukh and Nikhil Bhalerao (MBA BT Sem II)
honoured as Star Alumni. Also, PUMBA Art Exhibition,
wherein the paintings, sketches and photographs by the
students were displayed, was appreciated. Prof.
Aniruddha Joshi along with Abhimanyu Tadwalkar of
MBA BT 2nd year & Bhushan Astulkar MBA- BT 1st year,